MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION / COREVALVE, LLC. EVOLUT FX DELIVERY CATHETER SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number D-EVOLUTFX-2329

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/08/2022

Event Type  Injury  

Event Description

Initial placement of transcatheter aortic valve went well with good position at 3 mm deep to the annulus.While retrieving the deployment device, the valve was snagged by the tip of the cone and jumped out of the annulus.We attempted placement of an additional transcatheter valve.On our third deployment attempt, the valve spontaneously deployed from the device landing 7 to 10 mm deep on the noncoronary cusp.This valve dove deep into the ventricle.Patient had moderate aortic regurgitation around the cage with hemodynamic lability.Patient underwent removal of trans catheter valve and surgical aortic valve replacement.Fda safety report id# (b)(4).

• Brand Name: EVOLUT FX DELIVERY CATHETER SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION / COREVALVE, LLC.
• MDR Report Key: 15843993
• MDR Text Key: 304200789
• Report Number: MW5113407
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2023
• Device Model Number: D-EVOLUTFX-2329
• Device Lot Number: 0011404213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Hispanic
• Patient Race: White